Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding.

Objectives: To investigate safety and effectiveness of left atrial appendage closure (LAAC) in atrial fibrillation patients with prior major bleeding.

Methods: A total of 377 consecutive patients scheduled for LAAC with Watchman device were divided into bleeding group (n = 137) and non-bleeding group (n = 240). Data were compared between groups.

Results: The bleeding group had more patients ≥75 years old (P = 0.044), higher CHADS-VASc (P = 0.029) and HAS-BLED scores (P = 0.001) than the non-bleeding group. During the long-term follow-up, except for thromboembolism event (P = 0.031), the incidences of major bleeding  , all-cause death  , co-primary efficacy events  , and the cumulative survival ratio after adjustment of confounding factors    were comparable. The observed thromboembolism rate was reduced by 86.3% (P = 0.0002) and 55.1% (P = 0.0293) and the observed major bleeding rate was decreased by 61.9% (P = 0.0393) and 35.7% (P = 0.2426) compared with expected risks in bleeding and non-bleeding groups, respectively. The risk reduction in thromboembolism and major bleeding were significantly greater in bleeding group versus non-bleeding group (all P < 0.0001).

Conclusions: Among patients with prior bleeding, LAAC is a safe and effective alternative to anticoagulation therapy and seems to emerge as a higher efficacy in risk reduction of thromboembolism and major bleeding compared to those without prior bleeding.